Kornimate/medical-research-clean huggingface dataset:
effects of multimodal physical therapy in patients with lumbosacral radiculopathy

Conditions: Lumbosacral Radiculopathy

Summary: purposes of the study to investigate the effect of multimodal physical therapy on pain, daiablility h-reflex, and diffusion tensor imaging (dti) parameters in patients with lumbosacral radiculopathy.

participants will receive multimodal physical therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. patients will receive the intervention for six weeks. outcomes will be assessed at baseline and post-intervention.

Eligibility criteria:
inclusion criteria: * chronic (≥ 3 months) unilateral lumbosacral radiculopathy (lsr) * the lsr is due to paracentral l4-l5 or l5-s1 lumbar disc herniation * the lsr is confirmed radiologically by mri * the lsr is confirmed clinically by history and physical examination * the lsr is confirmed neurophysiological by soleus h-reflex assessment * body mass index less than 30 * 20-45 years of age exclusion criteria: * systematic disease * bilateral symptoms * lumbar spinal stenosis * previous surgery * steroid injection * spinal fracture * lumbar spinal stenosis * spinal deformity * spinal fracture * radiological evidence of bilateral nerve root encroachmen * evidence of h-reflex amplitude or latency affection on asymptomatic side

Keywords: lumbosacral radiculopathy lumbar disc herniation
dalfampridine and gait in spinocerebellar ataxias

Conditions: Spinocerebellar Ataxias Type 1; Spinocerebellar Ataxias Type 2; Spinocerebellar Ataxias Type 3; Spinocerebellar Ataxias Type 6

Summary: investigators expect there will be improvement in walking speed and steadiness after taking dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions for patients with spinocerebellar ataxia.

twenty spinocerebellar ataxia patients will be randomized to receive either dalfampridine or placebo over a total period of 10 weeks. after entering the study, patients will return every 2 weeks for evaluation. after four weeks, intervention will be stopped and patient will enter a 2-week wash out period where they do not take any drug. then, patients will be given the opposite treatment (dalfampridine or placebo) and this "crossover" study will be performed for another 4 weeks. investigators expect there will be improvement in walking speed and steadiness after taking dalfampridine, thereby improving activities of daily living and enhancing social and occupational functions.

Eligibility criteria:
inclusion criteria: * individuals at age 18 years or older. * individuals who can provide the informed consent * genetic confirmed definite spinocerebellar ataxias (sca) * able to complete two trials of the timed 25-foot walk at screening exclusion criteria: * patients who has severe ataxia and unable to ambulate. * any orthopedic condition that would affect motor performance. * patients with secondary ataxia from general medical disorders * individuals who have major psychiatric disorders that prevents compliance * history of epilepsy * patients with active drug or alcohol use or dependence that would interfere with adherence to study requirements * inability or unwillingness of subject or legal guardian/representative to give written informed consent.
human papilloma virus (hpv) vaccine trial in young adolescent women with glaxosmithkline biologicals' (gsk bio) hpv-16/18 vaccine

Conditions: Cervical Intraepithelial Neoplasia; Papillomavirus Infection

Summary: this protocol posting deals with objectives \& outcome measures of the extension phase up to month 48. the objective of the extension study is to evaluate the long-term immunogenicity of the hpv 16/18 l1 vlp as04 vaccine (for all subjects in the hpv vaccine group) by enzyme-linked immunosorbent assay (elisa). the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct00196924). the long-term follow-up study will be blinded until the primary study is unblinded and will be open for all visits subsequent to unblinding of primary study hpv-013 (nct00196924). during the open phase, only subjects who received the hpv-16/18 vlp/as04 vaccine during the primary study will continue their participation in the follow-up study until month 48. subjects in the control group (havrix®) will attend one further visit as their last study visit. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * a female who enrolled in the immunological subset of the 580299-013 study, received the three doses of vaccine/control according to the treatment allocation and completed the 580299-013 study. * written informed assent obtained from the subject and written informed consent obtained from a parent or legally acceptable representative of the subject. exclusion criteria: * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling. * administration of immunoglobulins and/or any blood products within the 3 months preceding blood sampling.

Keywords: prophylaxis hpv-16/18 infections and cervical neoplasia
nbt-nm108 as an early treatment for suspected or confirmed symptomatic covid-19 patients

Conditions: Suspected or Confirmed COVID-19

Summary: this open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using nbt-nm108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic covid-19 patients.


Eligibility criteria:
inclusion criteria: * aged between 18 to 79 (inclusive) * have mild to moderate covid-19-like symptoms based on the symptom list from cdc (updated may 13, 2020) and the severity categorization from fda \[18\]: a) mild covid-19 * fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea * no clinical signs indicative of moderate, severe, or critical illness severity b) moderate covid-19 * symptoms of moderate illness with covid-19 could include any symptom of mild illness or shortness of breath with exertion * clinical signs suggestive of moderate illness with covid-19, such as respiratory rate ≥ 20 breaths/min, oxygen saturation level \> 93% on room air at sea level, heart rate ≥ 90 beats/min * no clinical signs indicative of severe or critical illness severity * directed to home isolation by study physician * confirm study enrollment within 7 days of symptom onset * practice acceptable contraception, i.e., continue with current methods if participants are already practicing contraception, otherwise participants must agree to practicing contraception with a barrier method (male or female condom) or abstinence, from day 1 to day 35 or 7 days after the last dose of nbt-nm108 if they do not complete the 28-day intervention. * have access to a smartphone, tablet, computer, or other qualifying internet-enabled device and daily internet access * understand and be able to follow written and oral instructions in english * provide informed consent exclusion criteria * have tested positive for covid-19 and recovered * receiving vancomycin monotherapy or oral broad-spectrum antibiotics * inability to receive oral fluids * self-reported allergy or intolerance to any ingredients in nbt-nm108 * surgery involving the intestinal lumen within the last 30 days * documented diagnosis of celiac disease, inflammatory bowel disease or irritable bowel syndrome * pregnancy or breastfeeding * bariatric surgery * immunocompromised, e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled hiv/aids, prolonged use of steroids or other immunosuppressant medications

Keywords: covid-19 nbt-nm108 notitia biotechnologies company notitia biotechnologies microbiome microbiota gut microbiome gut microbiota corona virus novel corona virus sars-cov-2
using spoz technology to support and enhance the vitality acupunch (va) exercise program for older adults with dementia

Conditions: Cognitive and Behavioral Impairment; Sensory and Perceptual Impairment

Summary: this project aims to examine the effects of a six-month va exercise program incorporate the spoz technology in improving the cognitive behavioral impairment and sensory perceptual impairment of older adults with dementia in adult daycare centers.

a cluster-randomized controlled trial will be conducted to examine the effects of a six-month va exercise program incorporate the spoz technology in improving the cognitive behavioral impairment (using montreal cognitive assessment and neuropsychiatric inventory questionnaire) and sensory perceptual impairment (using pain assessment in advanced dementia) of older adults with dementia in adult daycare centers. using convenience sampling, 10 adult daycare centers with 122 older adults will be recruited, and then cluster-randomized by the daycare centers to an experimental or a control group. the experimental group will receive a 40-minute program 3 times a week for 6 months; the control group will maintain their routine activities. the two groups will be measured at three time points: before the intervention, and at three months and six months of the intervention.

Eligibility criteria:
inclusion criteria: * diagnosed as dementia by a physician, or * screened by the spmsq as dementia * age 65 and older exclusion criteria: * have severe cardiopulmonary disease * have physical mobility impairment * have spinal cord injury
electroacupuncture for preventing postoperative delirium in older adults undergoing total knee arthroplasty

Conditions: Postoperative Delirium

Summary: electroacupuncture may improve cognitive function and altered consciousness, but its effect on postoperative delirium in older arthroplasty patients remains unexplored. this study aims to assess the efficacy of electroacupuncture in preventing postoperative delirium in older adults undergoing total knee arthroplasty.

electroacupuncture combines traditional acupuncture with electrical stimulation at specific body points. recent clinical studies have shown promising results for acupuncture-related techniques in managing perioperative neurocognitive disorders. however, the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty remains unexplored.this randomised controlled trial aims to evaluate the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty.

Eligibility criteria:
inclusion criteria: * aged 65-90 years * american society of anaesthesiologists (asa) physical status class ii or iii * scheduled for elective unilateral total knee arthroplasty under general anesthesia exclusion criteria: * baseline dementia or mini-mental state examination (mmse) score below 24 * implanted electrical devices (eg, pacemakers, brain or spinal cord neurostimulator) * infection or abscess at any selected acupuncture point * severe hematopoietic or hemorrhagic disease * severe audio-visual impairments or inability to communicate in mandarin * alcohol or illicit drug misuse disorder * current use of sedatives, antidepressants or glucocorticoids * received acupuncture or electroacupuncture within one month before surgery * any condition deemed unsafe or unsuitable by the research team

Keywords: older adults electroacupuncture postoperative delirium total knee arthroplasty
denosumab vs zoledronate after vertebroplasty

Conditions: Denosumab Allergy; Zoledronic Acid Allergy

Summary: osteoporotic vertebral compression fracture (ovcf) patients had a proportion of secondary fractures after percutaneous vertebroplasty (pvp). denosumab and zoledronate acid is both effective to prevent bone loss for ovcf postmenopausal women. however, trial evidence comparing effect of denosumab vs zoledronate after pvp was unknown. the study aims to assess the efficiency of denosumab vs zoledronate for ovcf patients bone mineral density (bmd), bone turnover markers (btms), secondary fracture and adverse events after pvp.

whether denosumab was non-inferior than zoledronate in improving bone mineral density (bmd), bone turnover markers (btms), functional status questionnaires, and secondary fracture in elderly patients with ovcf after pvp remains unknown. a prospective, randomized, placebo-controlled clinical trial in ovcf patients with pvp was performed. this study aimed to investigate the efficiency of denosumab vs zoledronate on bmd, btms, functional status, secondary fracture rate, and adverse events in ovcf patients after pvp during a 12-month follow-up period.

Eligibility criteria:
inclusion criteria: * must be age between 50 and 90 years old * x-ray diagnosis of 1 or 2 segment vertebral compression fractures from t4 to l5 * bone mineral density t value less than -1 via dual-energy x-ray * a recent fracture history less than 6 weeks * mri show bone marrow edema of fractured vertebrae * low back pain, local paravertebral tenderness exclusion criteria: * must be able to have no intervertebral fissure * must be able to have no infection * must be able to have no malignancy * must be able to have no neurological dysfunction * must be able to have no previous use of anti-osteoporosis drugs * must be able to have no inability to perform magnetic resonance imaging * must be able to have no prior back open surgery * must be able to have no other established contraindications for elective surgery
the effect of intra-articular injection of regenogel-osp™(self-plasma) to treat pain following arthroscopic surgery

Conditions: Meniscal Tear

Summary: this study evaluates the efficacy of intra-articular administration of regenogel-osp™ to treat pain and the safety and efficacy on subject's activity and quality of life following arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be randomized and sequentially assigned to regenogel-osp™ or placebo treatment on a 1:1 basis.


Eligibility criteria:
inclusion criteria: * subject has signed and dated the informed consent form. * subject is a male or female over the age of 45. * patients scheduled for knee arthroscopic surgery due to degenerative or traumatic meniscal tear. exclusion criteria: * subject had any intra-articular injections to the intended study knee within 3 months prior to screening. * subject is unable to stop chronic administration of pain medications (including paracetamol), from the day before each study visit through completion of the study visit. * subject has a history of psoriatic arthritis, rheumatoid arthritis,or any other inflammatory condition associated with arthritis. * subject has a superficial wound in the area of the intended study knee. * subject is scheduled for knee ligaments reconstructive surgery. * subject has fever signs or symptoms of systemic infection or infection of the intended study knee. * subject has known sensitivity to any of the treatment components, egg, rubber or latex. * subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products. * subject has a clinically significant abnormal finding (e.g., laboratory result or ecg). * subject has known human immunodeficiency virus / acquired immunodeficiency syndrome (hiv/aids), hepatitis b or c viral infections, or acute or chronic liver disease. * subject has ever had cellulitis of the lower extremities, a superficial or deep vein thrombosis, or a family history of a clotting disorders. * subject receives any investigational device or product within 30 days of visit l. * subject is receiving an oral or injected anticoagulant. * subject ever abused drugs or alcohol (self-reported).
evaluation of glucose monitoring methods: characterizing glycemic control in subjects with diabetes

Conditions: Diabetes

Summary: evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.

many cgm systems use a surrogate for blood glucose--tissue glucose or interstitial glucose. interstitial fluid (isf) is the medium for these approaches. a physiological lag in isf glucose relative to capillary blood glucose has been noted, probably due to relatively low blood perfusion at the sampling site. 9 this physiological lag can result in an accuracy error, manifesting as a significant bias between blood and tissue glucose, particularly during periods of rapid glucose change. this lag error might be particularly meaningful when glucose is rapidly dropping towards hypoglycemia.

Eligibility criteria:
inclusion criteria: * adult * a1c \>7.4 within last 4 months * type 1 or 2 diabetes treated with basal/bolus insulin exclusion criteria: * under 18 years of age * unable to read/write english * allergy to adhesives * employee of cgm company

Keywords: continuous glucose monitoring accuracy
feasibility and accuracy of core temperature measurements using the esophageal temperature probe inserted through the gastric lumen of supraglottic airway device in pediatrics

Conditions: Temperature Change, Body; Supraglottic Airway Device; Pediatric ALL

Summary: in pediatric patients, the accuracy of body temperature measured with an esophageal temperature probe placed through the gastric lumen of the supraglottic airway device is investigated.

pediatric patients using a supraglottic airway device during general anesthesia are targeted. when the patient enters the operating room, standard monitoring is performed, general anesthesia is induced, a supraglottic airway device is installed, and an anesthesiologist inserts an esophageal thermometer through the gastric lumen. we recorded the body temperature measured in the esophagus, tympanic membrane, temporal artery, and rectum every 10 minutes from 10 minutes after insertion.

Eligibility criteria:
inclusion criteria: * pediatrics patients under six years old with asa ps 1-3 * patients undergoing general anesthesia using the supraglottic airway device * patient's weight: 10-30kg exclusion criteria: * patients who refused to participate in the study * patients with tumors in the esophagus or esophageal varices * patients with a monitoring device inserted through the esophagus during surgery * patients with ear inflammation * patients with congenital anomaly in the rectum * patients judged unfit to participate in the study by medical staff for other reasons
impact of individualized radiotherapy plan review in patients receiving adjuvant radiotherapy for breast cancer

Conditions: Breast Cancer

Summary: this study is being conducted to investigate the effect of a more in-depth education plan for patients with breast cancer. patients will be randomized to receive either the standard education plan during their breast cancer treatment or they will receive in-depth education about their breast cancer treatment. in order to see what kind of effect the different education plans have, patients will fill out three identical questionnaires during the course of treatment.

this study will be a prospective study of women receiving adjuvant radiation therapy for management of breast cancer at the university of california davis. all patients will be staged according to the american joint committee on cancer seventh edition. primary disease treatment information including surgical approach and utilization of adjuvant chemotherapy will be evaluated. all patients will have a validated quality of life assessment (facit-ts-ps) completed at three time points during their radiation therapy process. the patients will be randomized at the time of completion of radiation plan approval by the treating radiation oncologist in a one to one fashion to either proceed with standard education or more extensive plan review. the radiation oncology quality assurance (qa) process will be blinded to the randomization of the patient.

Eligibility criteria:
inclusion criteria 1. diagnosis of invasive breast cancer 2. ajcc stage 1, 2, 3 breast carcinoma 3. patient deemed clinically appropriate for adjuvant breast or chest wall radiation following surgery 4. women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy 5. patient must provide study specific informed consent prior to study entry 6. breast implants allowed exclusion criteria 1. stage 4 breast cancer 2. ductal carcinoma in situ 3. patients treated with radiation for palliative intent 4. prior treatment with radiation therapy to the ipsilateral breast or chest wall 5. prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry 6. prior invasive or in-situ carcinoma of the breast (-prior lcis is eligible) 7. diagnosis of dcis

Keywords: breast cancer ajcc stage 1, 2, 3 educational design radiation therapy treatment
secondary prophylaxis of gastric variceal bleed

Conditions: Gastric Varices

Summary: the purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the prevention of gastric variceal rebleeding and improvement in survival.


Eligibility criteria:
inclusion criteria: 1. cirrhosis 2. patients who had bled from gov2 or igv1（≥5 days and ≤ 28days） 3. presence of gastrorenal shunt exclusion criteria: 1. previous treatment of gastric varices, including endoscopic therapy, nsbb, tips, or surgery 2. non-cirrhotic portal hypertension 3. contraindications to cyanoacrylate injection or brto 4. portal cavernoma 5. hepatorenal syndrome 6. proven malignancy including hepatocellular carcinoma 7. end-stage renal disease under renal replacement therapy; 8. cardiorespiratory failure 9. pregnancy or patients not giving informed consent for endoscopic procedures
role of dietary habits in efficacy of bariatric surgery - study b

Conditions: Bariatric Surgery; Sleeve Gastrectomy; Obesity

Summary: the purpose of the study is to compare dietary habits after bariatric surgery in patients with poor weight loss versus good weight loss outcomes.

the obesity epidemic is a major public health concern with a significant economic burden in the usa. bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. among different types of bariatric procedures, sleeve gastrectomy (sg) has become the most commonly performed in usa. while sg is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. the mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. therefore, the purpose of the study is to compare dietary habits after bariatric surgery in patients with different weight loss outcomes.

Eligibility criteria:
inclusion criteria: * bariatric surgery (sleeve gastrectomy) patients exclusion criteria: * insulin-dependent diabetes * anemia * smoking * shift work within the past 1 year * drug or alcohol dependency * bipolar disorder * post traumatic stress disorder (ptsd)

Keywords: diet dietary habits weight changes